K171958 is an FDA 510(k) clearance for the PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE. This device is classified as a Drill, Bone, Powered (Class II - Special Controls, product code DZI).
Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on January 12, 2018, 197 days after receiving the submission on June 29, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K171958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2017 |
| Decision Date | January 12, 2018 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZI - Drill, Bone, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |